SP16 SERPIN-like Peptide Administration in Healthy Individuals

Healthy Participants Clinical Trial

Official title:

Safety, Tolerability and Pharmacokinetics of a Single Subcutaneous Administration of SP16-a SERPIN-like, Small Peptide Agonist of the Low Density Lipoprotein-like Receptor 1-in Healthy Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03651089
• Other study ID #: 01-SP16
• Status: Completed
• Phase: Phase 1
• Start date: July 16, 2018
• Est. completion date: January 23, 2019

Study information

• Verified date: July 2021
• Source: Serpin Pharma, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a randomized, double-blind, placebo-controlled Phase 1 Clinical Trial of 24 healthy individuals to test the safety, tolerability and pharmacokinetics of a single subcutaneous administration of Serpin Peptide 16 (SP16), a Serine Protease Inhibitor (Serpin)-like, small peptide agonist of the Low Density Lipoprotein Receptor-like Protein 1 (LRPP1) hypothesized to have anti-inflammatory activity.

Description:

One of the major determinants for outcome in patients with acute myocardial infarction (AMI) is the degree of inflammatory response. SP16 is a synthetic anti-inflammatory peptide developed to reproduce the anti-inflammatory activities of naturally occurring Serpins and has been tested as a treatment for AMI in mice. This Phase I trial will be the first to test the hypothesis that a single subcutaneous administration of SP16 is safe and well tolerated in healthy individuals, while also assessing the pharmacokinetic parameters of three different dosages. Participants will undergo direct clinical monitoring for up to 12 hours after drug administration. Additionally, participants will follow up with the same assessments at 24 hours, 48-72 hours and 7 days post drug administration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 23, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

Inclusion Criteria:

• Written informed consent

• Age 18 to 59 years

• Stated willingness to comply with all study procedures and availability for the duration of the study

• Ability to take oral medication and be willing to adhere to the medication regimen

• For females of reproductive potential: Use of highly effective contraception

• For males of reproductive potential: Use of condoms

Exclusion Criteria:

• Acute or chronic illness affecting organ function or requiring medications (including, but not limited to, cardiovascular, hepatic, renal hematologic, neurologic, dermatologic, psychiatric, or rheumatologic disease);

• Febrile illness within the previous 14 days;

• Known allergic reactions to components of the study agent;

• Treatment with another investigational drug or other intervention within 30 days;

• Current tobacco use or tobacco use within 60 days;

• Household contacts who are immunocompromised;

• Chronic infection(s) (of any kind);

• Malignancy (of any kind);

• Substance abuse disorder(s);

• Pregnancy or breastfeeding;

• Any other conditions that would place the subject at increased risk of adverse events or interfere with the conduct or interpretation of the study, in the opinion of the investigators.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• SP16
subcutaneous injection of experimental anti-inflammatory drug
• Placebos
subcutaneous injection of sterile saline

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Serpin Pharma, LLC	George Mason University, Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preliminary Safety Assessment: Occurence of adverse events	Occurence of adverse events	7 days follow-up
Secondary	Volume of distribution of SP16 in healthy subjects	Population estimate of volume of distribution will be calculated using non-compartmental analysis	7 days
Secondary	Clearance of SP16 in healthy subjects	Population estimate of clearance will be calculated using non-compartmental analysis	7 days

External Links

•   A phase 1 clinical trial of SP16, a first-in-class anti-inflammatory LRP1 agonist, in healthy volunteers